Os ITK revolucionaram a terapia da LMC, melhorando a sobrevida dos pacientes. No entanto esses resultados alertam para a relevância de estudos que avaliem os possíveis efeitos genotóxicos e mutagênicos dessa terapia a longo prazo. Uma vez que são escassas na literatura informações sobre o potencial genotóxico dos ITK na terapia da LMC, são necessários mais estudos para elucidar os mecanismos envolvidos com a finalidade de aprimorar o tratamento, bem como avaliar o impacto clínico que esse dano pode causar.
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APÊNDICE A
TERMO DE CONSENTIMENTO LIVRE E ESCLARECIDO PARA PARTICIPAÇÃO EM PESQUISA
Você está sendo convidado (a) como participante de uma pesquisa. Você não deve participar contra a sua vontade. Leia atentamente as informações abaixo e faça qualquer pergunta que desejar para que todos os procedimentos dessa pesquisa sejam esclarecidos. O projeto de pesquisa intitulado “Avaliação da expressão do gene BCR-ABL, do perfil mutacional, da genotoxicidade e citotoxicidade em pacientes com leucemia mielóide crônica tratados com inibidores de tirosino-quinase” tem como objetivo
principal avaliar a expressão do gene BCR-ABL, o perfil mutacional, a genotoxicidade e citotoxicidade de pacientes portadores de leucemia mieloide crônica em tratamento com inibidores da tirosina-quinase, em acompanhamento no ambulatório do Serviço de Hematologia do Hospital Universitário Walter Cantídio (HUWC), em Fortaleza-Ceará. Os resultados encontrados na pesquisa poderão contribuir para um melhor acompanhamento clínico dos pacientes com LMC e uma melhoria na qualidade de vida dos mesmos. A participação do(a) senhor(a) na pesquisa será plenamente voluntária e consciente, não havendo qualquer forma de pagamento ou compensação material. Para tanto, necessitamos que o Sr.(a) autorize a obtenção de 2 (dois) tubos de sangue (4 mL). A coleta de sangue será realizada em uma veia do braço de sua preferência, no Ambulatório de Hematologia do Hospital Universitário Walter Cantídio (HUWC). A participação na pesquisa, não irá lhe expor a nenhum risco que possa comprometer a sua saúde, havendo apenas o desconforto da dor e a possibilidade de formação de uma pequena mancha roxa devido à coleta do sangue. As amostras de sangue serão processadas em nosso laboratório, onde serão realizados as análises moleculares e os testes de toxicidade. O senhor(a) pode desistir de participar da pesquisa a qualquer momento, sem prejuízo de sua assistência médica. Sua identidade será mantida em sigilo absoluto, sendo a divulgação dos resultados totalmente proibida a terceiros, ficando restrita à discussão acadêmica de âmbito científico e, ainda assim, sem qualquer possibilidade de identificação dos pacientes. Será, no entanto, permitido o acesso às informações sobre procedimentos relacionados à pesquisa, como a coleta de informações sociodemográficas (sexo e idade), clínicas (sinais e sintomas) e laboratoriais (hematologia e bioquímica) dos prontuários médicos.
Em qualquer etapa do estudo, você terá acesso aos profissionais responsáveis pela pesquisa para esclarecimento de eventuais dúvidas. O principal investigador é Pedro Aurio Maia Filho, Laboratório de Hematologia, endereço: Rua Capitão Francisco Pedro, 1210 – Porangabussu, CEP 60430-370 - Fortaleza, CE – Brasil, Telefone: (85) 33668264.
Se o Senhor(a) tiver alguma consideração ou dúvida sobre a ética da pesquisa, entre em contato com o Comitê de Ética e Pesquisa (CEP) da UFC/PROPESQ- Rua Coronel Nunes de Melo, 1000 - Rodolfo Teófilo; Fone: (0xx) 85 3366-8344 (Horário: 8:00 às 12:00 h de segunda à sexta-feira). O CEP/UFC/PROPESQ é a instância da Universidade Federal do Ceará responsável pela avaliação e acompanhamento dos aspectos éticos de todas as pesquisas envolvendo seres humanos. O abaixo assinado _______________________________________, ____ anos, RG _________________, declara que é de livre e espontânea vontade a participação na pesquisa.
Caso o Senhor (a) sinta-se suficientemente informado a respeito das informações que leu ou que foram lidas para você sobre os propósitos do estudo, os procedimentos a serem realizados, seus desconfortos e riscos, as garantias de confidencialidade e de esclarecimentos permanentes e que sua participação é voluntária, que não há remuneração para participar do estudo e se o Senhor(a) concorda em participar solicitamos que assine no espaço abaixo.
Fortaleza, _____ de ________________ de _________.
____________________________________ _____________________________________
Assinatura do paciente/ representante legal Assinatura da testemunha _________________________________________